A Phase 2 Study of Triapine® (NSC #663249) and Cisplatin in Combination With Pelvic Radiation for Treatment of Stage IB2-IVa Cervical Cancer or Stage II-IV Vaginal Cancer
I. To determine three-month fasting F-18 fluorodeoxyglucose (FDG) positron emission
tomography (PET/CT) imaging complete metabolic response as defined by the European
Organization for Research and Treatment of Cancer (EORTC) PET study group.
I. To determine 6-month progression-free survival rate as calculated from the date of first
treatment until date of disease progression, relapse, or death.
II. To quantitate change in pre-treatment standard uptake value (SUV) on PET/CT and
post-treatment PET/CT or disease progression PET/CT.
III. To quantitate pre-treatment, during treatment and 3-mo post-treatment grade 2 or higher
gastrointestinal, genitourinary, and sexual function toxicity resulting from Triapine®,
cisplatin, and radiation therapy as measured by CTCAE v3.0, which will be utilized until
December 31, 2010; CTCAE v4.0 will be utilized beginning January 1, 2011.
IV. To associate smoking habit (non-smoker, smoker who quit during therapy, smoker) with
3-mo post-treatment PET/CT metabolic response and 3-mo best overall clinical response as
measured by RECIST criteria after Triapine®, cisplatin, and radiation therapy.
V. To associate HPV or non-HPV sub-type cervical cancer with 3-mo post-treatment PET/CT
metabolic response and 3-mo best overall clinical response as measured by RECIST criteria
after Triapine®, cisplatin, and radiation therapy.
OUTLINE: This is a multicenter study. Patients are stratified according to brachytherapy
treatment (planned intracavitary brachytherapy vs none).
Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV
on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo
pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo
parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as
Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months
after completion of study treatment, and at disease progression. Patients complete Sexual
Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at
3 months after completion of study treatment, and at disease progression.
After completion of study treatment, patients are followed periodically for up to 5 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Fasting F-18 Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET/CT) Imaging Complete Metabolic Response, Reported Following National Cancer Institute (NCI) and European Organization for Research and Treatment of Cancer (EORTC) Guidelines.
To quantitate change in pre-treatment standard uptake value (SUV) on PET/CT and posttreatment PET/CT or disease progression PET/CT. Change in PET/CT SUV will be associated with 3-month best overall clinical response.
post therapy at 3 months
Case Western Reserve University
United States: Food and Drug Administration
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